“Based off of an initial, and relatively brief, review of the rule, it appears FDA overlooked the majority of AFIA's comments on the supplemental proposed rule," said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, commenting on the Foreign Supplier Verification Programs (FSVP) rule.
The National Grain and Feed Association (NGFA) said it was pleased to see that some of the suggestions it made were heeded, said David Fairfield, vice president of feed services with the organization.
But he told us the final rule, part of the US Food Safety Modernization Act (FSMA), is not much different to the previous supplemental notice on the FSVP that the Food and Drug Administration (FDA) put out in September 2014.
Compliance dates start in 18 months from the publication of the final rule, said the FDA.
Importers are responsible to establish known or foreseeable hazards; determine the risk posed by a feed from the analysis and the supplier’s actions; use that information to pick suppliers and conduct verifications and corrective actions, said the agency.
Importers have to create written procedure regarding the verification process for approved suppliers and have to maintain and follow that plan for each item being imported.
Additionally, risk evaluations have to be redone at least every three years and when new information is available, they said. However, importers don’t have to evaluate the item or the supplier if there has been an adequate assurance the item will be processed for food safety in alignment with standards later in the supply chain.
The new FSVP rule includes a requirement the AFIA found to be unreasonable and impractical: “The FDA dedicated a section in the final rule to address certain circumstances where a hazard requiring a control is identified in food/feed, but foreign supplier verification is unnecessary, such as when the foreign supplier's customer controls the hazard,” said AFIA officials. “However, the final rule still requires an importer to obtain assurances from its customer that controls the hazard.”
One thing AFIA is pleased to see in the final rule is that FDA modified the definition of 'importer' and 'US owner or consignee,’ said Sellers. He said that modification provides clarification and ensures the entity responsible for FSVP compliance is the one who has a financial interest, knowledge and control over the supply chain.
FDA left modified FSVP requirements in place for certain types of importers and foreign suppliers; however, the agency aligned this with the regulations on preventive controls for human food and animal food — it amended the definition of ‘very small importer’ to be consistent with a ‘very small business’ under the preventive controls for animal food regulation.
AFIA had expressed objection to the inclusion of modified FSVP requirements in its December 2014 comments for ‘very small importer’ and ‘very small foreign suppliers’ saying it would create an unfair advantage to smaller foreign suppliers and importers over larger ones. Despite its disappointment, the trade group said it appreciates the qualifications are aligned with the preventive controls for the animal food regulation.
NGFA had asked for some exemptions to be applied to certain raw agricultural commodities like grains and oilseeds, noting the complex and commingled nature of commodity systems through which grains, oilseeds and other commodities move through the supply chain, said Fairfield.
To import those commodities, the importer needs to go through the foreign supply verification process, but grain elevators are not considered suppliers if they only store agricultural commodities, he said. So the importer would need to either verify production methods with the foreign farmers who raised the grain or do a hazard analysis and establish controls or get assurances from customers downstream.
“That’s one nuance that particularly affects the grain industry,” said Fairfield.
The rules also have some positive aspects, including greater flexibility for importers in demonstrating compliance and in regards to record keeping, he added.
The new rules also include details on third-party accreditation aiming to establish criteria under which the FDA would recognize and accredit third-party auditors that perform safety audits for such products.
The AFIA said it also was not in favor of some parts of the third-party verification rule, although it said it does support the overall requirements and the goal of the program.
The rule establishes different types of audits including those carried out by an FDA-recognized auditor and those undertaken by a consultant, or by a non-recognized auditor, said the AFIA. However, the FDA has included a requirement for the agency to review the audits carried out by recognized-auditors.
“FDA evaluation of complete audit reports is irrelevant," said Sellers. "In order for a facility to meet certification, all non-conformities will need to be corrected. The certificate acknowledging the facility meets the certification requirement is sufficient. FDA's access to sensitive information makes facilities unnecessarily vulnerable to inappropriate public access and use of confidential information.”
The FDA’s decision to insist on the ability to review the entire audit is disappointing because it may discourage facilities from having audits or limit the discussion, he said.
The FDA also is providing a webinar to inform industry about the final rules for FSVP and third party auditors on Monday, November 23.
Both the AFIA and NGFA said they too have information sessions in the pipeline on how members might go about implementing the requirements under the rule.
AFIA has training sessions organized for December 8 in Arlington, Virginia and on January 27 in Atlanta, Georgia.